US9895224B2 - Treatment catheter system - Google Patents

Abstract

A treatment catheter system for treatment of a heart valve includes a circumferential valve tissue structure and an elongate catheter member, and has an inner lumen, proximal and distal end portions. The system includes a catching component which can be positioned at the distal end portion of the catheter member to be non-separable from the catheter member. An outer member extends circumferentially around the catheter member. The circumferential valve tissue structure is correspondingly arranged between the catheter member and the outer member. A catching mechanism reduces a radial distance between the catheter member and the outer member to catch the valve tissue between the outer member and the catheter member via a catching opening to immobilize and treat the caught valve tissue on the distal end portion of the catheter member.

Description

The present application claims priority and benefit of U.S. provisional application No. 61/543,352, of German patent application No. 10 2011 054 176.4, of German patent application DE 10 2011 053 528.4, of U.S. provisional application No. 61/607,703, and of German patent Application 10 2012 101 877.4, the whole content of which applications is incorporated hereinto by reference.

TECHNICAL FIELD

Embodiments generally relate to a treatment catheter system comprising a catheter member and an outer member and to a method of using a treatment catheter system.

BACKGROUND

Heart valve diseases are affecting approximately 300,000 people worldwide each year. Those diseases translate in abnormal leaflet tissue (excess tissue growth, tissue degradation/rupture, tissue hardening/calcifying), or abnormal tissue position through the cardiac cycle (i.e. annular dilation, ventricular reshaping) leading to a degrading valve function like leakage/blood backflow (valve insufficiency) or a resistance to blood forward flow (valve stenosis).

Those diseases can be treated mostly by a surgical approach on a stopped heart requiring the use of a heart lung machine and in many cases by an invasive procedure. Some patients due to their general health status may be at higher risk or even contra-indicated for open heart surgery and may benefit from a treatment on a beating heart by catheter techniques.

Accordingly, a treatment catheter system, which allows interaction with tissue on a beating heart, is desirable.

SUMMARY

Various embodiments provide a treatment catheter system for treatment of a bloodstream valve, such as a heart valve, having a circumferential valve tissue structure, comprising an elongate catheter member, for example an elongate flexible catheter member, to be disposed at the interior of the circumferential valve tissue structure and to be removed therefrom after treatment, wherein the catheter member extends along a longitudinal axis and has an inner lumen and proximal and distal end portions, and wherein the catheter member comprises a catching component which is or can be positioned at the distal end portion of the catheter member to be non-separable from the catheter member at least when being positioned at the distal end portion of the catheter member and which at least when being positioned at the distal end portion of the catheter member comprises a lateral groove which extends transverse to the longitudinal axis and which opens to a lateral outer side to form a lateral catching opening, an elongate flexible outer member to be disposed at the exterior of the valve structure at a level of the lateral groove, wherein the outer member can at least partially extend circumferentially around the catheter member with valve tissue of the circumferential valve tissue structure being correspondingly circumferentially arranged between the catheter member and the outer member, and a catching mechanism operable by an interventional cardiologist or a surgeon and allowing reduction or increase of a radial distance between the catheter member and the outer member to catch at least part of the valve tissue between the outer member and the catheter member within the lateral groove via the catching opening to thereby immobilize the caught valve tissue on the distal end portion of the catheter member.

Embodiments of the invention further provide a method for surgical treatment of a bloodstream valve comprising a circumferential valve tissue structure of a patient using a treatment catheter system comprising a catheter member having a longitudinal axis and a lateral groove, and an elongate outer member, the method comprising placing the lateral groove of the catheter member in an interior of the circumferential valve tissue structure, placing the elongate outer member at least partially around an outside of the circumferential tissue structure at an axial level, with respect to the longitudinal axis, of the lateral groove, reducing a distance between the elongate outer member and the lateral groove to at least partially force tissue of the circumferential valve tissue structure into the lateral groove, and removing the catheter member and the elongate outer member from the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments are described with reference to the following drawings, in which:

FIG. 1 shows a treatment catheter system according to an embodiment in a partially cut schematic view;

FIG. 2 shows a partially cut perspective view of a catheter member of a treatment catheter system according to an embodiment;

FIG. 3 shows schematically the interaction of an outer member and a catheter member of a treatment catheter system according to an embodiment;

FIGS. 4ato 4dschematically show a treatment catheter system according to embodiments;

FIG. 5 schematically shows a catheter member of a treatment catheter system according to an embodiment;

FIG. 6 schematically shows an embodiment of a catheter member of a treatment catheter system according to an embodiment;

FIGS. 7-9 illustrate a method for using a treatment catheter system according to an embodiment;

FIGS. 10-12 show an exemplary embodiment of an outer member catheter;

FIGS. 13aand 13bshow a view of a catheter member of a treatment catheter system and a prosthesis according to an embodiment; and

FIG. 14 shows an exemplary embodiment of a prosthesis that is implantable using the treatment catheter system.

DESCRIPTION

The following detailed description refers to the accompanying drawings that show, by way of illustration, specific details and embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention. Other embodiments may be utilized and structural, logical, and electrical changes may be made without departing from the scope of the invention. The various embodiments are not necessarily mutually exclusive, as some embodiments can be combined with one or more other embodiments to form new embodiments.

With reference to the figures, atreatment catheter system2 for treatment of aheart valve4 having a circumferentialvalve tissue structure6 according to an embodiment comprises anelongate catheter member8 to be disposed at the interior10 of the circumferentialvalve tissue structure6 and to be removed therefrom after treatment of theheart valve4, wherein thecatheter member8 extends along alongitudinal axis12 and has an inner lumen14 (cf. for exampleFIG. 2) and proximal18 and distal16 end portions, wherein thedistal end portion16 is to be disposed inside of a human or animal body, and theproximal end portion18, for example, may be kept outside of the human or animal body and may be connected to ahandle19 for being manually operable, for example by an interventional cardiologist or a surgeon, and wherein thecatheter member8 comprises a catchingcomponent20 which is or can be positioned at thedistal end portion16 of thecatheter member8 to be non-separable from thecatheter member8 at least when being positioned at thedistal end portion16 of thecatheter member8 and which at least when being positioned at thedistal end portion16 of thecatheter member8 comprises alateral groove22 which extends transverse to thelongitudinal axis12 and which opens to a lateralouter side24 to form a lateral catchingopening26. Thelateral groove22 may be axially spaced apart from an end of the proximal and/ordistal end portions17,18. Thelateral groove22 may be formed by a substantially smooth surface geometry, i.e. thelateral groove22 and the catchingopening26 may not include any hooks or barbs or protrusions or projections or other features that might interfere (e.g. penetrate) with tissue in thelateral groove22.

Theheart valve4 may have acircumferential tissue structure6 and an annulus4c. The heart valve may be connecting two heart chambers (e.g.ventricular chamber4aandatrial chamber4b) and anaxial direction4d(c.fdouble arrow4dinFIG. 13b) of thevalve4 may be defined between the two chambers the valve is connecting.

Thetreatment catheter system2 further comprises an elongate flexibleouter member28 to be disposed at the exterior30 of the circumferentialvalve tissue structure6 at a level of thelateral groove22, wherein the elongate flexibleouter member28 may at least partially extend circumferentially around thecatheter member8 with valve tissue of the circumferentialvalve tissue structure6 being correspondingly (at least partially) circumferentially arranged between thecatheter member8 and the elongate flexibleouter member28.

Thetreatment catheter system2 further comprises a catching mechanism32 (which, for example, includes thelateral groove22 and the elongate flexible outer member28) operable, for example, manually operable by an interventional cardiologist or a surgeon, to reduce a radial distance D1 (cf. for exampleFIG. 7) between thecatheter member8 and the elongate flexibleouter member28 to catch at least part of the valve tissue between the elongate flexibleouter member28 and thecatheter member8 within thelateral groove22 via the catchingopening26 to thereby immobilize the caught valve tissue on thedistal end portion16 of thecatheter member8. Thecatching mechanism32 may also be operable to increase the radial distance D1 in order to facilitate a removal of the elongate flexibleouter member28 and thecatheter member8. The elongate flexibleouter member28 may also remain around the valve tissue, wherein the elongate flexibleouter member28 may be of a self-disruptive material. The elongate flexibleouter member28 may also be cut after treatment to thereby remove the engagement between the elongate flexibleouter member28 and the valve tissue (at least partially) circumferentially engaged by the elongate flexibleouter member28.

As mentioned above, inFIG. 1 thetreatment catheter system2 according to an embodiment is illustrated in a state when being applied to the mitral valve as theheart valve4 to be caught, immobilized and treated. However, thetreatment catheter system2 may also be applied to other heart valves, such as for the tricuspid valve and/or for the aorta valve and/or for the pulmonic valve. Further, thetreatment catheter system2 may also be applied to other hollow body tissue structure allowing to be correspondingly caught between the innerflexible catheter member8 and the elongate flexibleouter member28.

The elongate flexibleouter member28 may be a wire or a thread or a chain or any other appropriate elongate flexible means allowing to be guided around the circumferential valve tissue structure. The elongate flexibleouter member28 can also be a hollow component enabling supply of a substance to thevalve4 or surrounding tissue. The elongate flexibleouter member28 may be disposed completely around the circumferentialvalve tissue structure4 to form a closed ring therearound. However, the elongate flexibleouter member28 may also be in the shape of an open ring in as far as it is able to force the valve tissue to be caught in thelateral groove22 into saidlateral groove22. In order to provide for the catching force for forcing the valve tissue into thelateral groove22, that is in order to provide for the reduction of the radial distance D1 between theinner catheter member8 and the elongate flexibleouter member28, thecatching mechanism32 may be provided by or may comprise the contractability of the elongate flexibleouter member28. That is, the elongate flexibleouter member28 may be provided to be contractible, wherein the elongate flexibleouter member28 may be itself of a substantially non-elastic and non-contractible material, wherein the contracting of the elongate flexibleouter member28 may be achieved by tightening the elongate flexibleouter member28 in a lasso or snare manner. The elongate flexibleouter member28 may also be of a shape-memory material, wherein the elongate flexibleouter member28 may then self-contract when in place around the circumferentialvalve tissue structure6 and when certain environmental conditions (for example, temperature conditions are met). In this respect, the elongate flexibleouter member28 may be of nitinol. The elongate flexibleouter member28 may also be of an elastic material, wherein the elongate flexibleouter member28 may be arranged around the circumferentialvalve tissue structure6 in an elastically expanded state and may then self-contract by the corresponding elastic restoring forces.

As an alternative to the use of the elongate flexibleouter member28 as providing, or contributing to, thecatching mechanism32 or in addition to the elongate flexibleouter member28 contributing to the formation of the catching mechanism, the catchingcomponent20 may comprise an expandable portion, within which thelateral groove22 is provided, and which can be radially expanded against the inner side of the elongate flexibleouter member28, whereby the valve tissue is rather pushed into thelateral groove22 or both pushed and dragged into thelateral groove22 if both theinner catheter member8 and the elongate flexibleouter member28 are expanded and contracted, respectively. In this respect, the expandable portion of the catchingcomponent20 may be of a shape-memory material or may be of an elastic material.

To facilitate handling, e.g. during insertion and approach to the tissue, around which the elongate flexibleouter member28 is placed to catch tissue in thelateral groove22 of thecatheter member8, the elongate flexibleouter member28 may be sheathed in anouter member catheter29. Theouter member catheter29 may comprise a tubular body and an inner lumen (not shown), through which the elongate flexibleouter member28 may be guided to the heart, for example to theheart valve structure6, and may be forwarded around the valve tissue structure and then retracted into theouter member catheter29 to change/reduce a distance D1 between theinner catheter member8 and the elongate flexibleouter member28. Theouter member catheter29 may be flexible. Theouter member catheter29 may be made from plastic material, such as polymers, or metal or any other material. Theouter member catheter29 may for example be an “active catheter”, i.e. a catheter that moves and/or bends actively according to a control signal, actuated for example by shape memory alloy (e.g. nitinol) components heated and/or cooled by electro-thermal converters (e.g. Peltier elements) or actuated by hydraulic actuators. Theouter member catheter29 may also comprise a separate sheath for each end of the snare-shape elongate flexibleouter member28 in the lumen of theouter catheter member29, whereby all of the sheaths of theouter member catheter29 may be movable relative to each other and/or relative to theouter catheter member29 to facilitate positioning of the elongate flexibleouter member28.

In the following, an exemplaryouter member catheter29 is described in more detail. However, it is to be appreciated that thetreatment catheter system2 may also be used with other outer ember catheters29 (or without an outer member catheter29) and is not limited to the embodiments that are described in the following paragraphs.FIG. 10 shows a crossectional view of a distal portion of an exemplaryouter member catheter29 located in the vicinity of the circumferentialvalve tissue structure6.FIGS. 11aand 11bshow a perspective view of theouter member catheter29 andFIG. 12 shows how awire400 and a catchingwire410 are placed around thecircumferential tissue structure6 of aheart valve4 that connects aventricular chamber4aand anatrial chamber4bof a human heart in order to provide the elongate flexibleouter member28 extending around thetissue structure6 from a viewpoint that is located in theatrial chamber4b. In this respect, elongate flexibleouter member28 may bewire400 and/or catchingwire410 or a part thereof.

With reference toFIGS. 10 to 12, the outer member catheter29 may comprise an elongate primary catheter170 which has an inner lumen180 and which extends along a longitudinal axis190 and has a distal end portion200, first220 and second230 elongate secondary catheters each comprising a distal end portion240,250 and an inner lumen260,270, and each to be disposed in the inner lumen180 of the elongate primary catheter170 to be moveable relatively thereto and exposable from the distal end portion200 thereof, and a first flexing mechanism291 to provide the distal end portion240,250 of the first220 and/or second230 secondary catheter with a tendency to assume a first secondary bent shape, wherein the distal end portion240,250 of one or both of the first and second secondary catheters220,230 is provided to be able to be flexed by the first flexing mechanism291 to form an arm portion226,236 substantially transverse to the direction of the longitudinal axis190 of the primary catheter170 to assume the first secondary bent shape, when being exposed from the distal end portion200 of the elongate primary catheter170, and wherein the respective arm portion226,236 optionally extends at least 4 mm or at least 5 mm or at least 8 mm or at least 10 mm or at least 12 mm in a direction radial to the longitudinal axis190 of elongate primary catheter170 with a free end of the respective arm portion facing away from the longitudinal axis190 so that the respective arm portion226,236, with a lateral outer surface thereof, forms a blunt end face extending transversely to the longitudinal axis190 of the elongate primary catheter170 and allowing to frontally contact the circumferential valve tissue structure6 with the outer catheter member29 in a non-penetrating manner to prevent or reduce trauma or injuries. First220 and second230 secondary elongate catheters may each be extending along alongitudinal axis225,235, may each also comprise a proximal end portion280,290, and may each comprise a secondary alignment portion227,237, which may be located between the distal240,250 and proximal end portions280,290 and adjacent to thedistal end portion240,250. A second flexing mechanism292 may provide the secondary alignment portion of the first220 and/or second230 secondary catheter with a tendency to assume a second secondary bent shape. Thearm portions226,236 of the first220 and second230 secondary catheters, respectively, may extend in generally opposite directions to each other when the secondary alignment portions227,237 of the first220 and second230 secondary catheters assume the second secondary bent shape, e.g. in parallel to each other. Optionally, the second secondary bent shape may have a predetermined curvature, for example with a radius of substantially 30 to 70 mm and/or describing an angle of 90° to 270°.

Theouter member catheter29 may further comprise first300 and second310 elongate tertiary catheters to be guided by the first220 and second230 secondary catheter, respectively, each extending along alongitudinal axis320,330 and each comprising adistal end portion360,370 and a proximal end portion380,390 and each to be moveable relatively to the first220 and second230 secondary catheters, respectively, and exposable from thedistal end portion240,250 thereof.

The first300 and second310 tertiary catheters may each have a first341,351 and/or a second342,352 tertiary alignment portion between the respective distal360,370 and proximal380,390 end portions thereof, each with a shape-memory structure (e.g. comprising Nitinol or a spring element or the like) providing the first341,351 and/or the second342,352 tertiary alignment portions with a tendency to assume a first and/or a second tertiary bent shape, respectively, corresponding to the first and/or to the second secondary bent shape, respectively.

Thedistal end portions360,370 of the first300 and the second310 tertiary catheters may comprise a shape-memory structure providing them with a tendency to assume a respective bow-shape when being exposed from thedistal end portion240,250 of the first and secondsecondary catheters220,230, respectively.

The shape-memory structure of thedistal end portions360,370 of the first300 and the second310 tertiary catheters may be such that, when the first341,351 and/or the second342,352 tertiary alignment portion of the first300 and the second310 tertiary catheters are located to mate with the distal end portions and/or the secondary alignment portions327,237 of the first and secondsecondary catheter220,230, assuming their respective first and/or second bent shape, respectively, thedistal end portions360,370 of the first200 and the second310 tertiary catheters are provided with a tendency to assume bow-shapes extending oppositely towards to each other to form a loop-shape.

Further, the first341,351 and/or the second342,352 tertiary alignment portion of the first300 and the second310 tertiary catheters of theouter member catheter29 may be located to mate with thedistal end portions240,250 and/or the secondary alignment portions227,237 of the first and secondsecondary catheter220,230, assuming their respective first and/or second bent shape, respectively, thedistal end portions360,370 of the first300 and the second310 tertiary catheters are fully operatively exposed from thedistal end portions240,250 of the first220 and second230 secondary catheters.

The first and seconddistal end portions360,370 of the first300 and second310 tertiary catheter are exposed from thedistal end portion240,250 of the first220 and second230 secondary catheters, thedistal end portions360,370 of the first300 and second310 tertiary catheters each substantially extend in a substantially same plane that is transversal to thelongitudinal axis190 of theprimary catheter170 of theouter member catheter29.

The first300 and second310 tertiary catheters of theouter member catheter29 each may comprise aninner lumen340,350, wherein awire400 having a freedistal end405 is provided in theinner lumen340 of the firsttertiary catheter300 and a catchingwire410 with a catchingcomponent415 on a distal end thereof may be provided in theinner lumen350 of the secondtertiary catheter310, and wherein both thewire400 and the catchingwire410 are provided to be movable relative to their respectivetertiary catheter300,310 and exposable from and retractable into adistal end portion360,370 thereof, so that the freedistal end405 of thewire400 can be caught with the catchingcomponent415 to form a loop around thecircumferential tissue structure6 that may serve as and/or be the flexibleouter member28 as described herein.

The catchingcomponent415 may be a catching basket and/or a lasso and/or a snare.

The curvature of the second secondary bent shape may mate to the curvature of anaortic arch440 of a mammal heart and thecircumferential tissue structure6 is part or all of the mitral valve apparatus.

The curvature of the second secondary bent shape may mate to the curvature of a connection channel from the superior vena cava to the pulmonary artery of a mammal heart and thecircumferential tissue structure6 may be part or all of the tricuspid valve apparatus of a mammal (e.g. human) heart.

The elongateprimary catheter170 of theouter member catheter29 may further comprise afront body tube420 moveably disposed in itsinner lumen180, wherein thefront body tube420 may comprise a bluntfront body430 on its distal end portion that is configured to selectively open and close thedistal end portion200 of the elongateprimary catheter170 by movement of thefront body tube420 in a distal or proximal direction, respectively, of the elongateprimary catheter170 of theouter member catheter29.

One or both of the first300 and second310 tertiary catheters may be received in theinner lumen260,270 of the first220 and second230 secondary catheter of theouter member catheter29, respectively, to be guided by them.

The first300 and/or second310 tertiary catheter may comprise aninner lumen340,350, wherein one or both of the first220 and second230 secondary catheter, respectively, may be received in theinner lumen340,350 of the first300 and/or second310 tertiary catheter, respectively, so that the first300 and/or second310 tertiary catheter may be guided by the first220 and second secondary230 catheter, respectively. While in the above paragraphs an exemplaryouter member29 is described, otherouter member catheters29 that may at least partially or fully surround the circumferentialvalve tissue structure6 may be utilized with the invention. It must also be appreciated that noouter member catheter29 may be necessary at all ifouter member28 is placed at least partially or fully around the valve tissue structure6 (e.g. an outside thereof) in another way or by another means.

Arrows5 inFIG. 10 schematically indicate possible directions for reversible kinematic movement of components of theouter member catheter29.

In the following, thecatheter member8 and the catchingcomponent20 are described in more detail. The catchingcomponent20 may be separate from thecatheter member8 and may be provided to be insertable into theinner lumen14 from theproximal end portion18 of thecatheter member8 and may be forwardable through theinner lumen14 to thedistal end portion16 to be exposed to the outside of thecatheter member8 at saidproximal end portion18. Correspondingly, the catchingcomponent20 may then be retracted through theinner lumen14 of thecatheter member8 and may be removed from thecatheter member8 at thedistal end portion16 thereof. However, when placed at thedistal end portion16 of thecatheter member8, the catchingcomponent20 cannot be removed from thecatheter member8 in order to ensure that the catchingcomponent20 will not accidentally remain within the interior of thevalve tissue structure6 when retracting thecatheter member8 therefrom.

The catchingcomponent20 may also be integrally formed with thecatheter member8 at thedistal end portion16 of thecatheter member8 or fixedly attached to thecatheter member8 at thedistal end portion16 thereof to provide astationary catching component20, that is stationary and non-moveably with respect to thecatheter member8. In this respect, the catchingcomponent20 may be formed by a tip body providing a tip end portion of thecatheter member8 at thedistal end portion16 thereof.

The catchingcomponent20 may be generally made of a solid body, in which a lateral transverse recess is formed to provide thelateral groove22. The catchingcomponent20, however, may also be formed by a grid-type or mesh-type cage body36 (cf. for exampleFIG. 4b) comprising grid elements37 or mesh elements, respectively, wherein the grid elements37 may be formed by respectiveelongate wires38 which are forwardable through theinner lumen14 of the catheter member8 (cf. for example embodiment ofFIGS. 4a-4d,5 and6). Thewires38 themselves may be arranged within elongateflexible sheaths39 and may be moveable relative to theirrespective sheath39 to be forwardable and retractable therethrough. The catchingcomponent20, for example, thewires38 thereof, may be made from steel (e.g. comprising iron, chromium and carbon), from nickel, from alloys substantially comprising nickel (e.g. nichrome, e.g. nitinol), from polymer (e.g. PVC, PP, PS, polyamide or aromatic polyaramides), from titanium, from alloys substantially comprising titanium (e.g. Ti 6Al 4V), from platinum, from gold, from aluminium or from alloys substantially comprising aluminium. The catchingcomponent20 may be made from other materials as well. The catchingcomponent20 may be made by casting techniques. The catching component may be made by metal-cutting manufacturing techniques.

The grid-type or mesh-type cage body36 may be retractable into theinner lumen14 of thecatheter member8. Forwarding and/or retracting of the wire body36 (e.g. basket) may be actuated manually, or by an electric motor.

Thecage body36 may have a reinforcing liner40 (cf. for exampleFIG. 6) of tubular shape and which may be arranged circumferentially at the inner circumferential side of thecage body36 or at the outer circumferential side of thecage body36. Theliner40 may be made from the same material as thecage body36. Theliner40 may also be made from a different material than thecage body36. Theliner40 may be made from steel (e.g. comprising iron, chromium and carbon), from nickel, from alloys substantially comprising nickel (e.g. nichrome, e.g. nitinol), from polymer (e.g. PVC, PP, PS, polyamide or aromatic polyaramides), from titanium, from alloys substantially comprising titanium (e.g. Ti 6Al 4V), from platinum, from gold, from aluminium or from alloys substantially comprising aluminium. Theliner40 also may be made from other materials.

Theliner40 may be joined to thecage36 by gluing, soldering, welding or other means. Theliner40 may also be elastic and may be inserted within thecage body36 to be elastically clamped against the circumferential inner side of thecage body36 or may be arranged around thecage body36 to be elastically clamped against the circumferential outer side of thecage body36.

Theliner40 may be of a mesh-type body40 having a mesh size D2, or a sheet of foil material comprising holes therein. The mesh size D2 of theliner40 may be smaller than a mesh-size of a mesh-type cage body36 or than a circumferential distance of grid elements of a grid-type cage body36. For example, the mesh size D2 may be equal or less than 50%, 30% or 20% of the mesh size of a mesh-type cage body36 or of the circumferential distance of grid elements of a gridshape cage body36. Theliner40 may be a foil-material substantially not comprising holes.

Thecage body36 may be placed and/or located in the interior10 ofcircumferential tissue structure6 so that thelateral groove22 is located on the side of theventricular chamber4aof the annulus4cof anatural valve4, e.g. having a distance from the natural valve annulus4c, i.e. thelateral groove22 may be placed to be a sub-annularlateral groove22.

The catchingcomponent20 may comprise a temporaryartificial heart valve42. The temporaryartificial heart valve42 may be fixedly attached to the catchingcomponent20, for example fixedly attached to thecage body36. The temporaryartificial heart valve42 may be attached to theliner40. The temporaryartificial valve42 may be radially compressible. The temporaryartificial valve42 may be radially expandable. The temporaryartificial valve42 may be compressed when in theinner lumen14 of thecatheter member8. The temporaryartificial valve42 may be expanded when forwarded from theinner lumen14 of thecatheter member8 to the outside thereof. The temporaryartificial valve42 may be provided to enable a prolonged operation procedure without the risk of creating valve insufficiency.

The grid-type or mesh-type cage-body36 as part of the catchingcomponent20 and part of the catchingmechanism32, allows to safely clampcircumferential valve tissue6 between thecage body36 and theouter member20, wherein nevertheless a blood flow is allowed between for example,ventricular chamber4aandatrial chamber4bthrough the gaps between the grid elements and/or mesh elements, wherein themesh type liner40 does not substantially limit blood flow. Accordingly, a treatment of the heart can be carried out on the beating heart, wherein a slight back flow during the contraction period of the heart may be accepted, which slight back flow may be further reduced or even prevented when using the above described temporaryartificial valve42. The device shown inFIG. 2 may allow only small blood through flow so that treatment time may be correspondingly reduced.

Thecage body36 may be terminated by a substantially non-compressiblefront body44, e.g. a distalend portion plug44. Thefront body44 may have a rounded outer side. Thefront body44 may have a blunt front nose. Thefront body44 may have an outer diameter slightly larger than an inner cross-sectional diameter of theinner lumen14 of thedistal end portion16 of thecatheter member8 to be able to provide a plug for closing a frontal end opening of theinner lumen14 of thecatheter member8.

Thefront body44 may be connected to some or all of thewires38 forming thecage body36 in order to bias or prestress thecage body36. Thefront body44 may be attached to some or all of thewires38 forming thecage body36 in order to combine them at thelongitudinal axis12 of thecatheter member8, wherein the front body may be correspondingly arranged coaxially to thelongitudinal axis12 of thecatheter member8. Thecage body36, that is, for example, thewires38 and/or the grid- or mesh-type body thereof, may converge its/their front end, and may correspondingly converge towards thefront body44.

The non-compressiblefront body44 may serve several functions: to seal theinner lumen14 of thecatheter member8 when the catchingcomponent20 is retracted into theinner lumen14 of thecatheter member8 and/or to facilitate atraumatic insertion and positioning of thecatheter member8 by providing a conical tip.

Thelateral groove22 may extend continuously or in an interrupted manner around the whole circumferential perimeter of the catchingcomponent20 traverse to thelongitudinal axis12. Thelateral groove22 may be formed around only a partial circumferential perimeter, e.g. forming an arc of a circle equal or less than 30, 45, 90, 180, or 270 degrees. Thelateral groove22 may also be formed by the transversely (transverse to longitudinal axis12) extending recesses (cf.FIG. 2).

Thelateral groove22 may be provided on thecage body36 of the catchingcomponent20 in a manner to be provided on eachwire38 or on one wire or a on plurality of wires or on each but one wire forming thecage body36 so that eachgroove22 extends transverse to thelongitudinal axis12 of the catheter member8 (cf. for exampleFIGS. 4band6).

Thelateral groove22 on thecage body36 may be provided by radially and inwardly bent portions of each or of some of thewires38 forming thecage36, i.e. thegroove22 may be provided without removing material but by bending (cf. for exampleFIGS. 4band6), wherein the bent portions are provided at substantially the same level along thelongitudinal axis12.

Wires38 orarms38 forming thecage body36 may be arranged to have the same angular or circumferential distance from each other. Wires orarms38 forming thecage body36 may be arranged to have different angular or circumferential distances between eachwire38.

Wires38 forming thecage body36 may be arranged to form a substantial round (transverse to the longitudinal axis12)cage body36 that is coaxially positioned and aligned with thelongitudinal axis12 of thecatheter member8, at least when thecage body36 is extended on thedistal end portion16 of thecatheter member8.Wires38 forming thecage body36 may be arranged to form a substantially triangular-shaped or rectangular-shaped or pentagonal-shaped or hexagonal-shaped or dodecagonal-shaped or other polygonal-shapedcage body36 that is coaxially positioned and aligned with alongitudinal axis12 of thecatheter member8, at least when thecage body36 is extended on adistal end portion16 of thecatheter member8. Thecage body36 may also be arranged to be not coaxially aligned with thelongitudinal axis12 of thecatheter member8, e.g. excentrically aligned with thelongitudinal axis12 of thecatheter member8.

As shown e.g. inFIG. 13a, thelateral groove22 may define a distal cage section22athat may be the part of the catching component20 (e.g. when it is formed as cage body36) that is located on a distal side of the lateral groove22 (along the longitudinal axis12) and a proximal cage section22bthat may be the part of catching component20 (e.g. cage body36) that is located on a proximal side of the lateral groove22 (along the longitudinal axis12). Thecage body36 and/or the catchingcomponent20 may have a curvature or bent shape, that, when seen in a direction perpendicular to thelongitudinal axis12, changes the curvature from a concave curvature of thelateral groove22 to a convex curvature at the transition between thelateral groove22 and the distal cage section22aand/or the proximal cage section22b, as it is show, e.g. inFIGS. 13aand13b.

In this respect, the catchingcomponent20/cage body36 may have a diameter at an axial level (with respect e.g. to longitudinal axis12) of thelateral groove22 that is smaller than a diameter of a natural valve annulus4c. The catchingcomponent20/cage body36 may have a diameter at an axial level (with respect e.g. to longitudinal axis12) adjacent to thecatheter member8 that approaches the crossectional diameter of thecatheter member8 and is smaller than a diameter of a natural valve annulus4c.

With reference to e.g.FIGS. 13aandb, diameters and/or axial lengths of the catching component20 (e.g. cage body36) may be configured so that distal cage section22amay be located/placed at least partially (e.g. substantially) in anatrial chamber4band that proximal cage section22bmay be located/placed at least partially (e.g. substantially) in the interior10 of the circumferentialvalve tissue structure6 with thelateral groove22 being located on a ventricular side (that is the side of theventricular chamber4a) of the natural valve annulus4cwhile having a (small) distance to said annulus4c, e.g. at least when thecage body36 is forwarded fromcatheter member8.

A diameter of the catching component20 (e.g. of the cage body36) may have a radial diameter (with respect to longitudinal axis12) in its distal cage section22athat is larger than a radial diameter in its proximal cage section22b, at least when thecage body36 is forwarded form theinner lumen14 ofcatheter member8 and is fully expanded. A longitudinal extension length (with respect to longitudinal axis12) of the distal cage section22amay be shorter than a longitudinal length of the proximal cage section22b. A radial diameter (with respect to the longitudinal axis12) ofcatheter member8 may be smaller than a diameter of catching component20 (e.g. cage body36), at least when the catchingcomponent20 is forwarded from thecatheter member8. With respect tolongitudinal axis12, a radial diameter of the distal cage section22amay increase in distal direction alonglongitudinal axis12 starting fromlateral groove22 to a maximum diameter and then may decrease again so that the distal cage section22amay form a convex profile (c.fFIG. 13a, however embodiments may comprise an even more distinctive convex profile). The proximal cage section22bmay form a convex profile with increasing and then decreasing radial diameters (with respect to longitudinal axis12) from a bottom oflateral groove22 longitudinally along catchingcomponent20 in a proximal direction alonglongitudinal axis12.

Thecatheter member8 may be a hollow tubular body, wherein theinner lumen14 or additional lumens may have such a cross-sectional diameter that one re treatment tools for treating the caughtvalve tissue6 or valve tissue adjacent to the caught valve tissue can be simultaneously arranged therein and are movable relative therethrough. Such treatment tools may include aperforation component48 for perforating thevalve tissue6, or drug supplying tools allowing supply of a drug, such as, for example, anticalcification drugs, drugs against tissue proliferation, drugs against thrombus formation or for platelet activation, to thevalve tissue6 to be treated.

The catchingcomponent20 may be movable relative to thecatheter member8. The catchingcomponent20 may be configured to be forwarded and retracted relative to thecatheter member8 according to a control-command. The catchingcomponent20 may be fully sheathed in alumen14 of thecatheter member8 when fully retracted. The catchingcomponent20 may be integrally formed with thecatheter member8 at thedistal end portion16.

The catchingcomponent20 may comprise a conical and/or blunt front part and may be arranged on thecatheter member8 so as to be exposed at thedistal end portion16 of thecatheter member8, thereby being configured to cause least tissue damage when thecatheter member8 is inserted and forwarded to the tissue to be treated.

Theperforation component48 may comprise or may be a needle, a hollow needle or anothertubular body48 comprising an inner lumen54 and having a sharpened or peaked end. Theperforation component48 may be provided such that it can be forwarded and retracted through one, some or all of the wire sheaths39 of thewires38 forming the cage body36 (cf. for exampleFIG. 4d) in order to perforate tissue. Theperforation component48 may be provided in theinner lumen14 or any additional lumen of thecatheter member8, for example in parallel and separate from thesheaths39 andwires38 such as to perforatetissue6 that is caught in alateral groove22 of the catchingcomponent20. Theperforation component48 may be configured to carry ananchor component50 to perforate the caught tissue with saidanchor component50 which then remains at the tissue when thecatheter member8 is retracted. Theanchor50 may be placed on a tip of theperforation component48. A chord, for example an artificial chord, for example of ePTFE, nylon or Kevlar,52 may be fixedly attached to theanchor50. Thechord52 may be used to replace a ruptured native chord of for example a mitral or tricuspid valve. Theanchor50 may be configured to allow joining of adjacent layers of tissue together, e.g. to join two, three or four layers of tissue or a plurality of layers of tissue together. In this regard, a so-called edge-to-edge mitral valve repair (Alfieri stitch) may be carried out by having, for example, half of the circumferential mitral valve tissue caught in thelateral groove22 and having oppositely arrange tissue parts perforated by theanchor50 on the perforation component48 (cf. for exampleFIGS. 7-8). Thechord52 may be positioned in an inner lumen54 of theperforation tool48. Theperforation component48 may be designed so that theanchor50, after it is fixated to tissue or adjacent layers of tissue, remains fixated to the tissue when thecatheter member8 is retracted. Thereby tissue may remain joint together after theperforation component48 has been retracted. Similarly, achord52 may remain attached to theanchor50 which is in turn fixated to tissue and/or joining together tissue after thecatheter member8 has been retracted.

Theperforation component48 may be provided with a needle, e.g. a hollow needle. The needle may be used to deliver drugs and/or substances to tissue.

Theperforation component48 may be flexible and/or the needle may flexible. Theperforation component48 may be rigid and/or the needle may rigid or may have a rigid end portion.

Theperforation component48 may also be a separate part outside of thecatheter member8 and may be sheathed by a separate sheath (not shown), within which it is moveably received. Theperforation component48 may be forwarded through thecatheter member8 through theinner lumen14 of thecatheter member8 and/or through thesheath39 of awire38 forming thecage body36 of the catchingcomponent20.

According toFIG. 1, thecatheter member8 and the elongate flexibleouter member28 are positioned relative to each other such that the elongate flexibleouter member28 and thelateral groove22 are arranged in a manner thatvalve tissue6 is forced, for example dragged, into thelateral groove22 via the catchingopening26 by the elongate flexibleouter member28 when a radial distance D1 (cf. for exampleFIG. 2) between the elongate flexibleouter member28 and thecatheter member8 is reduced. This results in thevalve tissue structure6 being immobilized in thelateral groove22 by being caught in thelateral groove22 and retained therein by the elongate flexible outer member28 (see also e.g.FIGS. 2 and 3). The immobilization of the valve tissue or otherwise heart tissue allows safe treatment of said immobilized tissue, for example, for carrying out heart valve reconstruction orheart valve4 replacement by a valve prosthesis.

The radial distance D1 between the elongate flexibleouter member28 andcatheter member8 is reduced by a catchingmechanism32, which is operable by an interventional cardiologist or a surgeon or any other person. In all embodiments, the catchingmechanism32 may include a lasso or snare formed by the flexibleouter member28 to allow the operator to contract the snare and to thereby reduce the radial distance D1 between the elongate flexibleouter member28 and the catheter member8 (cf.FIGS. 1, 4a,4band4d). In some embodiments, the catchingmechanism32 may be actuated e.g. by a servo motor or directly by the hands of the operator.

FIG. 2 shows a more detailed, partially cut perspective view of acatheter member8 according to an embodiment, which may be used as catheter member in the embodiment ofFIG. 1. Generally, thecatheter member8 is of an elongated, tubular design. In some embodiments, thecatheter member8 may comprise different radii, diameters and/or bevels to facilitate insertion in the heart and approach to aheart valve4.

The catchingcomponent20 at thedistal end portion16 of thecatheter member8 comprises alateral groove22 that extends transverse of thelongitudinal axis12 of thecatheter member8. Thelateral groove22 provides a catchingopening26 on a circumferentialouter side24 of the catchingcomponent20. Via the catchingopening26,heart valve tissue6 can be caught in thelateral groove22 by interaction of the catchingcomponent20 with the flexible outer member28 (not shown inFIG. 2) so thatvalve tissue6 is immobilized between the flexibleouter member28 and thelateral groove22. According toFIG. 2, the catchingcomponent20 is formed as a tubular member which longitudinally extends through thecatheter member8 and is moveable relative to thecatheter member8 in the longitudinal direction thereof and/or rotationally. Thereby, the catchingcomponent20 itself defines an inner lumen coincident with theinner lumen14 of thecatheter member8, and through which the operation tools are guided towards thedistal end portion16. The catchingcomponent20 ofFIG. 2 may also be integrally formed at thedistal end portion16 of thecatheter member8. Further, the catchingcomponent20 may include longitudinalinner channels46 respectively assigned to operation or treatment tools such as theperforation component48 which may be guided therein. Thecatheter member8 may also be a flexible solid body having longitudinal guiding channels defining theinner lumen14 as a plurality of separate lumens and guiding the operation or treatment tools to thedistal end portion16, where they may be aligned with the afore-discussedinner channels46 in the catchingcomponent20.

In this embodiment, the catchingcomponent20 is also equipped with anelongate perforation tool48, e.g. a needle orhollow needle48, to perforate or puncture the caught valve tissue or adjacent valve tissue in order, for example, to attach ananchor50 with a chord52 (see e.g.FIG. 4cfor an illustrative embodiment ofanchor50 and chord52) to thevalve tissue6 or tissue adjacent to thevalve4. For this, ananchor50 with or without an attachedchord52 may be guided through theinner lumen64 of thehollow needle48 into thelateral groove22.

Thehollow needle48 loaded withanchor50 and/orchord52 is contained in theinner lumen14 of thecatheter member8 and can be controlled by an interventional cardiologist or a surgeon or another person to move it forward towards thedistal end portion16 and en route perforate valve tissue caught in thelateral groove22. Afterwards, thehollow needle48 can similarly be controlled to fully retract backwards towards theproximal end portion18 so that it is fully sheathed by thecatheter member8. Theanchor50 can be forwarded through thehollow needle48 and be exposed at the distal end thereof to thereby enter into the perforation created by the needle. Theanchor50 may then remain seated in the valve tissue with thechord52 extending through the valve tissue.

InFIG. 2, thehollow needle48 is shown for in an intermediate position with its tip extending into thelateral groove22.

In other embodiments, (instead of an anchor) drugs or other substances (e.g. to improve medical imaging) and/or devices for treatment or interaction can be applied to the caught valve tissue by thehollow needle48 in the catchingcomponent20. In some embodiments, thehollow needle48 can be exchangeable so that an optimal needle can be chosen to e.g. attach ananchor50 to thevalve tissue6 or deliver drugs or so that thehollow needle48 can be replaced once the tip of the needle is worn after use. In some embodiments, the elongate perforation component48 (e.g. the hollow needle48) may be flexible so that it may be guided laterally out of the lateral groove to penetrate laterally located tissue to, for example, forward a drug thereto.

In the embodiment shown inFIG. 2, the catchingcomponent20 is moveable relative to thecatheter member8 and can be forwarded or retracted via theinner lumen14 of thecatheter member8 to cause least collateral damage to tissue during insertion of thecatheter member8. In other embodiments, the catchingmember20 is integrally formed with thecatheter member8 at thedistal end portion16 of thecatheter member8.FIG. 2 illustrates the catchingcomponent20 in a position, where it is forwarded from theinner lumen14 of thecatheter member8 and (apart from the for illustrative purposes not fully retraced needle48) is ready to interact with the elongate flexibleouter member28 in order to dragvalve tissue6 in thelateral groove22.

Thecatheter member8 may be made flexible to be bendable along its longitudinal direction.

InFIG. 2, thedistal end portion16 of thecatheter member8 is shown with a conical and rounddistal end portion16, whereas thedistal end portion16 may also be blunt.

FIG. 3 shows schematically the interaction of the elongate flexibleouter member28 and thecatheter member8 of atreatment catheter system2 to immobilizetissue6 of avalve4 according to one embodiment. InFIG. 3, the radial distance D1 between the elongate flexibleouter member28 andcatheter member8 has been reduced to catchtissue6 of thevalve4 in thelateral groove22 located at thedistal end portion16 of thecatheter member8 via the catchingopening26. InFIG. 3, the path along which theflexible perforation component48 can be forwarded and retracted in order to perforate thevalve tissue6 according to one embodiment indicated by a dashedline70.

Thelateral groove22 may be designed to have different geometric dimensions. The larger thelateral groove22 is, the more tissue of thecircumferential tissue structure6 can be caught in thelateral groove22, thereby the length of leaflet tissue along the surface oflateral groove22 may be increased, thereby theperforation component48 may perforate the leaflet tissue in two areas. In this case, ananchor50 may be designed to be positioned to fixate the two perforated positions together. Theanchor50 may be fixated in each of the two perforated positions. This is creating locally a shrinkage or shortening of the leaflet length (e.g. the circumferential tissue structure6) in an axial direction of thecircumferential tissue structure6. This may be done at several locations of the tissue structure6 (e.g. by using one ormore arms38 of thewire body36, each comprising a lateral groove22) so that a uniform shortening of the leaflet may be obtained. The inner basket (e.g. wire body36) may also comprise a tissue that can be stapled on the native leaflet (e.g. to the circumferential tissue structure6).]

FIG. 4aandFIG. 4bshow atreatment catheter system2 according to another embodiment. With reference toFIGS. 4aand 4b, the elongate flexibleouter member28 and thecatheter member8 are disposed aroundtissue6 of aheart valve4, in this case again themitral valve4, however elongate flexibleouter member28 andcatheter member8 can be arranged to interact with other heart valves such as the tricuspid valve, the pulmonic valve, or the aortic valve.

Thedistal end portion16 ofcatheter member8 is shown positioned in such a way that it is ready for interaction with the elongate flexibleouter member28. In this embodiment, the catchingcomponent20 of thecatheter member8 contains an extendable andretractable cage body36, formed byelongate wires38 which exit thecatheter member8 at the distal end thereof and which are circumferentially spaced to define as grid elements thecage body36. Thewires38 are connected to each other at their distal ends.

The catchingcomponent20 can be extended from theinner lumen14 and/or retracted into theinner lumen14 of thedistal end portion16 of thecatheter member8.

InFIG. 4a, thewires38 forming thecage body36 are in a position where they are retracted in thelumen14 of thedistal end portion16. In some embodiments, thewires38 are strained and/or compressed to contain elastic energy when being retracted in thelumen14 of thedistal end portion16, so that they radially self-expand when being moved out of theinner lumen14 of thecatheter member8.

According toFIGS. 4aand 4b, thedistal end portion16 is terminated by a substantially non-compressiblefront body44, e.g. a distalend portion plug44, having a rounded outer side (here, the front body is of ellipsoid shape) and having an outer diameter slightly larger than an inner cross-sectional diameter of thelumen14 of thedistal end portion16 of thecatheter member8 to be able to provide a plug for closing a frontal end opening of theinner lumen14 of thecatheter member8. A front wire orstring58 may be provided to help guiding thecatheter member8 to the final position in the heart. Theend portion plug44 of thedistal end portion16 can be conical as shown inFIGS. 4aand 4bto facilitate positioning thecatheter member8 in the heart and/or other human or animal organs, wherein theplug44 may have a blunt front end or nose.

In some embodiments, thefront body44 is connected to some or all of thewires38 forming thecage36 in order to radially confine thecage36 at the distal end thereof.

In some embodiments, the non-compressiblefront body44 can serve several functions: to seal theinner lumen14 of thecatheter member8 when the catchingcomponent20 is retracted into theinner lumen14 of thecatheter member8 and/or to facilitate atraumatic insertion and positioning of thecatheter member8 by providing a conical tip.

InFIG. 4b, thetreatment catheter system2 is shown with the catchingcomponent20 extended from thedistal end portion16 of thecatheter member8. Thewire cage body36 is radially expanded by elastic energy stored in the strained/compressed wires38. The radial expansion of thewire cage body36 may also be achieved by an auxiliary expansion device, such as a radially expandable (for example via inflation) balloon arranged within thecage body36 and expandable in a controlled manner.

InFIG. 4aor4b, the catchingmechanism32 is formed by the radially contractible loop design of the elongate flexibleouter member28 in combination with the radiallyexpandable cage body36 and thelateral groove22 defined by thewires38 of thecage body36. The catchingmechanism32 can be operated by an interventional cardiologist or a surgeon to reduce the radial distance or gap D1 between the elongate flexibleouter member28 andcatheter member8 so thattissue6 of themitral valve4 gets caught and immobilized in thelateral groove22 between the elongate flexibleouter member28 and theinner catheter member8.

When the tissue of thevalve4 is caught and immobilized as described above with reference toFIGS. 4aand 4b, interaction and/or treatment with the tissue, for example valve repair or reconstruction, can be safely and reliably carried out.

FIG. 4candFIG. 4dshow an embodiment of thetreatment catheter system2 that is similarly designed as the embodiment described with reference toFIG. 4aandFIG. 4band which also allows interaction, e.g. fixating ananchor50 with or without achord52 or the delivery of substances or drugs to the tissue of thevalve4 or adjacent tissue via aperforation component48.

FIG. 4cshows an enlarged view of the area indicated by a frame inFIG. 4b. In this embodiment of thetreatment catheter system2, thewires38 that form thecage body36 are arranged in hollowtubular sheaths39 which comprise a respectiveinner lumen60. When tissue of thevalve4 is caught in thelateral groove22 by the elongate flexibleouter member28 and thereby gets immobilized, the elongateflexible perforation tool48, e.g. theflexible needle48 may be extended from thelumen60 of one or a plurality of thesheaths39. Theflexible perforation tool48 may be designed as described above and, hence may be a hollow needle or a solid needle and may be configured to fixate ananchor50 and/or achord52 with thetissue6 of thevalve4.FIG. 4cshows theflexible perforation tool48 withanchor50 andchord52 attached to its tip while perforatingtissue6 to thereby fixateanchor50 in thetissue6 of thevalve4. The end of thechord52 opposite to theanchor50 can e.g. be attached to surrounding tissue, for example in the papillary muscle or the ventricular apex, at the discretion of the operator.

In other embodiments, theperforation tool48 can be configured to deliver drugs or other substances to the tissue of thevalve4.

In other embodiments, the perforation tool or aneedle48 may not be provided in aninner lumen60 of awire38 forming thecage body36, but may be separate from thecage36 and be independently forwarded through the inner lumen of thecatheter member8 and operable independently.

FIG. 4dshows thetreatment catheter system2 after theanchor50 has been fixated to the tissue of thevalve4. A radial distance D1 between the elongate flexibleouter member28 and thecatheter member8 has been increased by releasing the previously radially contracted elongate flexibleouter member28, and the catching component20 (comprising the wire cage body36) is partially retracted into thedistal end portion16 of thecatheter member8 and has been removed from theheart valve4 and the elongate flexibleouter member28. The tissue of theheart valve4 that is immobilized between thelateral groove22 and the elongate flexible the elongate flexibleouter member28 may be released by increasing the distance betweencatheter member8 and the elongate flexibleouter member28 by operating the catching mechanism32 (i.e. the length of the elongate flexibleouter member28 is increased resulting in larger circumferential length of the elongate flexible outer member28). In other embodiments, thetissue6 ofvalve4 may be released by retracting catchingcomponent20 includingwire cage36 back into thedistal end portion16 of catheter member8 (i.e. reducing the circumferential diameter of lateral groove22). In some embodiments, the catchingmechanism32 is operated to increase the circumferential length of the elongate flexibleouter member28 and the catchingcomponent20 is retracted at the same time in order to release thetissue6 caught betweenlateral groove22 and the elongate flexibleouter member28.

FIG. 5 shows an embodiment of acatheter member8 of atreatment catheter system2 according to an embodiment. The embodiment is similar to the embodiments described with reference toFIGS. 4ato 4c. In this embodiment, however, thelateral groove22 is formed by thesheaths39 forming thecage body36 of catchingcomponent20, thesheaths39 having a respective lateral recess therein at the level of thelateral groove22 thereby circumferentially forming thelateral groove22 in an interrupted manner. Thewire cage body36 is retractable into thedistal end portion16 ofcatheter member8 and can be expanded from a retracted position. The tips of thesheaths39 forming thecage36 are shown inFIG. 5 as being straight/blunt, whereas they may also be conical. The interaction of thecatheter member8 and the elongate flexible outer member28 (not shown inFIG. 5) to catch and immobilizetissue6 of a heart valve4 (not shown inFIG. 5) in thelateral groove22 via thelateral catching opening26 is similar to the embodiments described previously. Thesheaths39 forming thecage36 have aninner lumen60 allowing forwarding and retracting aflexible perforation component48, e.g. aneedle48, through thelumen60 into thelateral groove22 and back into thelumen60 of thesheaths39 forming thecage body36. One or more of thesheaths39 may also be substituted by a solid body, for example a wire having no inner lumen.

WhileFIG. 5 shows an embodiment where thelateral groove22 is formed or defined by a recess on eachsheath39 forming thecage body36, there may be other embodiments where only one or only some of thesheaths39 forming thecage body36 comprise a recess forming/defining thelateral groove22. In this respect, when a radial distance D1 between the elongate flexibleouter member28 and thecatheter member8 is reduced, tissue is only firmly caught and immobilized on thosesheaths39 forming thecage body36 that comprise a recess defining thelateral groove22.

The elongate,flexible perforation tool48, e.g. a needle orhollow needle48, is configured to perforate or puncture the caughtvalve tissue6 or adjacent valve tissue in order to attach an anchor with or without a chord, e.g. as previously described (not shown inFIG. 5), to thevalve tissue6 or tissue adjacent to thevalve4. For this, an anchor with or without an attached chord may be seated on the tip of thehollow needle48 and the chord may be led through the lumen of the hollow needle48 (only if the embodiment comprises a chord).

Thehollow needle48 loaded with anchor and chord is contained in theinner lumen14 of thecatheter member8 and can be controlled by an interventional cardiologist or a surgeon to move forward towards thedistal end16 and en route perforate valve tissue caught in thelateral groove22. Afterwards, theneedle48 can similarly be controlled to be fully retracted backwards towards the proximal end portion18 (cf.FIG. 1) so that it is fully sheathed in thelumen60 of thesheaths39 forming thecage body36. The anchor remains seated in thevalve tissue6 with the chord extending from the anchor. In some embodiments, the other end of the chord on the side opposite to the anchor is fixated e.g. to tissue surrounding thevalve4.

InFIG. 5, thehollow needle48 without an anchor or chord is shown in an intermediate position with its tip extending into thelateral groove22.

With reference toFIG. 6, another embodiment of acatheter member8 of atreatment catheter system2 is shown. Thecatheter member8 shown inFIG. 6 is and operates similar to the one shown inFIGS. 4ato 4dand comprises acatheter member8 having adistal end portion16 with a catchingcomponent20, awire cage36, a temporaryartificial heart valve42, a substantially non-compressiblefront body44 and a leading wire orstring58. The temporaryartificial heart valve42 is arranged within thecage36 and is fixedly attached to the inner side of thecage36. In the expanded condition of thecage36, the temporaryartificial heart valve42 is deployed from a compressed condition and can temporally take over the function of thenative valve4 as long as the catchingcomponent20 is positioned within the interior of the circumferentialvalve tissue structure6. A lateral sealing function is achieved by the engagement of thevalve tissue structure6 within the circumferentiallateral groove22. The embodiment shown inFIG. 6 further comprises an additional reinforcingmesh62. Themesh62 may be made from flexible wire, thread, polymer or any other material and is connected to thesheaths39 of thewires38, thesheaths39 also contribute to forming thecage36 at a distal end portion of thecage36 in a way that it forms a tubular mesh-liner62 inside thecage body36 when the catchingcomponent20 is extended from thecatheter member8. Themesh62 may improve the mechanical stability of thecage body36 and/or the mechanical stability of the temporaryartificial valve42. Embodiments that do not feature a temporary artificial heart valve42 (e.g. the embodiment shown inFIG. 5) also can comprise amesh62 as described above in order to improve mechanical properties.

In other embodiments, instead of an anchor, drugs or other substances (e.g. to improve medical imaging) and/or devices for treatment or interaction can be applied to the caughtvalve tissue6 by one or more needle(s)48 in the catchingcomponent20. In some embodiments, the needle(s)48 can be exchangeable so that an optimal needle can be chosen to e.g. attach ananchor50 to thevalve tissue6 or deliver drugs or so that theneedle48 can be replaced once the tip of theneedle48 is worn after use. In all embodiments, the elongate perforation component(s)48 (e.g. the needle(s)48) may be flexible.

In any or all embodiments, theperforation component48 may comprise alumen60 through which a medicaldrug supplying component64, e.g. ahollow needle64, can be forwarded and retracted to deliver drugs or substances. This enables thetreatment catheter system2 according to some embodiments to use theperforation component48 to attach ananchor50 to and/or interact with tissue of thevalve4 and then forward ahollow needle64 via theperforation component48, i.e. theperforation component48 serves two functions: to interact with tissue of thevalve4 and to serve as a sheath for ahollow needle64 to deliver drugs or substances. The medical drug may also be forwarded directly through theinner lumen60 of thehollow perforation component48.

Some of thesheaths39 containingwires38 for forming thecage36 may be configured to allow forwarding of ananchor50 with or without achord52 therethrough, while at the same timeother sheaths39 may be configured to deliver drugs and/or other substances.

While thecage36 is shown inFIGS. 4ato 4candFIGS. 5 to 6 to comprise fourwires38, in other embodiments it can comprise one wire, two wires, three wires, five wires or a plurality ofwires38, depending on the operational needs.

Similarly, thewires38 formingcage36 can be arranged on a (same) circle, each having the same or a different angular distance from each other. If thecage36 comprises fourwires38, these can be arranged on a circle having an angular distance of 90 degrees each from each other. In other embodiments, they can be arranged on a circle having arbitrary angular distances between each other, e.g. 170 degrees between a first and a second wire, 30 degrees between the second and a third wire, 69 degrees between the third and a fourth wire (which results in an angle of 360 degrees−170 degrees−30 degrees−69 degrees=91 degrees between the fourth wire and the first wire). Therefore, two ormore sheaths39 may be arranged to have a small angular distance, e.g. smaller or equal 1 degree, 5 degrees, 10 degrees or 15 degrees. Therefore, it is possible to deliver a drug or substance through afirst sheath39 so that the area in which theanchor50 is fixated (through a second sheath39) can be treated with a drug or substance before theanchor50 is fixated, while theanchor50 is fixated or after theanchor50 is fixated.

In other embodiments, thewires38 are not forming a substantiallyround cage36 as shown inFIG. 4atoFIG. 4candFIGS. 5 to 6, but e.g. a triangular-shapedcage36, a rectangular-shapedcage36 or a polygonal-shapedcage36.

In yet other embodiments, thecage36 may comprise a plurality ofsheaths39, but not allsheaths39 may be configured to guide forwarding and/or retracting of aperforation component48 through their inner thelumen60. If e.g. thecage36 comprises foursheaths39, only one or two or threesheaths39 may be configured to guide forwarding and/or retracting of aperforation component48, while the remaining sheath(s)39 may not comprise an inner lumen60 (i.e. may be solid bodies).

One or moreadditional perforation components48 may be provided that can be extended separately and independently from thewires38 of thewire cage36 out of thedistal end portion16 of thecatheter member8.

None of thesheaths39 may comprise aperforation component48 and there may only be one or more perforation component(s)48 that can be extended from thedistal end portion16 of the catheter member that are separate and independent from thesheaths39.

Some embodiments of thetreatment catheter system2 may comprise an inflatable balloon coated with drugs or substances in thedistal end portion16 of thecatheter member8. The balloon can be forwarded through theinner lumen14 of thecatheter member8 and can be inflated by the operator to come in contact with heart tissue, thereby delivering the drugs on its surface to the tissue it is in contact with. The balloon may also be deflatable by the operator in order to facilitate retraction of thecatheter member8 from the heart.

All embodiments of thecatheter member8 may be configured to deliver drugs or other substances to heart tissue and/or other tissue. Such substances can for example comprise a plasmid coding for a certain protein. The protein can e.g. be expressed by the native leaflet cells and can serve as a treatment of theleaflet4 or surrounding tissue. For that purpose, an adequate electrical field or other energy source may be applied between the elongate flexibleouter member28 and the catchingcomponent20 in order to achieve the opening of holes in the cell membrane (e.g. electro-poration) to promote plasmid entry inside the cells. The elongate flexibleouter member28 and the catchingcomponent20 may comprise electrodes (or, as an alternative, if they are made from electrically conducting materials like metals, may act as electrodes themselves without comprising additional electrodes) that are connected to an electric energy source via electrically conducting means, e.g. via electric wires that are sheathed in aninner lumen14 ofcatheter member8 and/or are sheathed in an inner lumen ofouter member catheter29, respectively. Thecatheter member8 and/or theouter catheter member29 may serve as electrically conducting means without additional means like wires if they are made from an electrically conducting material. The energy source may be placed outside the human body and may comprise a control means to selectively control voltage, current and/or direction of the current of the electric energy source. The energy source may be a battery (e.g. producing a direct current (DC)) or may be an alternator (e.g. producing alternating current (AC)) or may be any other source of AC and/or DC electric current. The electric charge of catchingcomponent20 may have an electric polarity opposite to a polarity of the elongate flexible outer member28 (and/or their respective electrodes). The control means may e.g. produce a square-wave voltage or a saw-tooth voltage or a sine-shaped voltage or any other periodic or non-periodic voltage that may be conducted to the electrodes of the elongate flexibleouter member28 and/or the catching component20 (or to the elongate flexibleouter member28 and/or the catchingcomponent20 themselves, if they do not comprise additional electrodes but act as electrodes themselves) via the electrically conducting means or via thecatheter member8 and/or theouter catheter member29 themselves, if they are made from electrically conducting material. The electric field that thereby may be established between the elongate flexibleouter member28 and the catching component20 (e.g. between their respective electrodes) may interact with tissue and open holes in the cell membranes of cells, e.g. of cells that form theheart valve4 and/or a papillary muscle of a heart and/or any other heart cell so that substances may diffuse or be moved by the electric field through the open holes into the inside of cells. The holes may close again, when voltage and/or current of the electric energy source are interrupted by the control means on the discretion of an interventional cardiologist or a surgeon, resulting in the substance being “caught” in the cells. Substances can include substances that improve medical imaging, e.g. substances containing radioactive isotopes or substances changing electromagnetic properties of the tissue in order to improve visibility and/or contrast using electro-magnetic imaging techniques such as X-ray imaging (e.g. angiography or echocardiography), magnetic resonance imaging or other medical visualization techniques.

In embodiments of thecatheter member8, the catchingcomponent20 which is or can be positioned at thedistal end portion16 of thecatheter member8 is designed to be non-separable from thecatheter member8, at least when positioned at thedistal end portion16 of thecatheter member8.

With further reference toFIGS. 13a, 13band14, thetreatment catheter system2 according to the present invention may be used to interact with one orseveral prosthesis500, e.g. to implant theprosthesis500. Accordingly, theprosthesis500 may optionally be a part of thetreatment catheter system2. Theprosthesis500 may generally be flexible. Theprosthesis500 may generally have a toroidal shape (e.g. when no substantial external forces act on it) having alongitudinal axis510 and an outer diameter D3 that is defined substantially perpendicular tolongitudinal axis510. Theprosthesis500 may have a curvature and an outer diameter D3 that is corresponding to the catchingopening26 and/or thelateral groove22 so that theprosthesis500 may be configured to be located in thelateral groove22, for example in addition to tissue (e.g. of circumferential tissue structure6) and/or the elongateouter member29. That is, diameter D3 ofprosthesis500 may be equal to a width oflateral groove22 in a direction oflongitudinal axis12 or may be smaller (for example, D3 plus a thickness of the tissue of thecircumferential tissue structure6 of a human heart multiplied by two may be equal to the width of thelateral groove22 along longitudinal axis12). The dimensions of theprosthesis500 may further be defined by a radius R1 that is defined between a central point530 (which may be a point on thelongitudinal axis12 of thecatheter member8 for example when theprosthesis500 is at least partially forced into thelateral groove22 as it is described below) and thelongitudinal axis510 and an extension angle α that is defined between two end portions (in a direction along longitudinal axis510) of theprosthesis500. The extension angle may define a full circle (i.e. 360°) or less than a full circle, e.g. approximately 5 to 15°, 15° to 30°, 30 to 45°, 45° to 60°, 60° to 80°, 80° to 110°, 110° to 150° or 150° to 180° or any combination or subset of the mentioned intervals or any other angle. Theprosthesis500 may also have a length L alonglongitudinal axis510 that is defined between the two end portions (L, α, D3 and D4 may geometrically be related to each other, c.f.FIG. 14). With respect to length L that is depicted inFIG. 14, it must be noted that L describes the length ofprosthesis500 along itslongitudinal axis510 when it is straight and not bent and not a length of an arc. In this respect, theprosthesis500 may generally describe a “C-shape”. Further, the geometric dimensions of theprosthesis500 may be selectively changeable, i.e. D3, R1 and/or a may be selectively changeable, e.g. on the discretion of a surgeon. Theprosthesis500 may comprise andinner lumen520 that may be extending from one end portion to the other end portion ofprosthesis500 alonglongitudinal axis510. In this respect, D3 may define the outer diameter of theprosthesis500 and a diameter D4 may define the inner diameter (i.e. the ‘outer’ diameter of inner lumen520). Theinner lumen520 and its diameter D4 may be configured so that theprosthesis500 may be surrounding, e.g. at least partially or fully surrounding, theouter member29. For example, theprosthesis500 may be adapted so that it can slide along the elongate flexibleouter member28 while being beaded on the elongate flexibleouter member28 withinner lumen510 surrounding the elongate flexibleouter member28. Accordingly, theprosthesis500 may be flexible so that it may follow a curvature of the elongate flexibleouter member28 when sliding over the elongate flexibleouter member28. Theprosthesis500 may be adapted to be fixed to tissue of the circumferentialvalve tissue structure6 and/or to the annulus4cof aheart valve4, for example using hooks, clips or screws530 as shown inFIGS. 13aandbor by other means. In this respect, theprosthesis500 and theinner lumen520 thereof may be adapted so that clips or screws530 or other means of fixation may be forwarded from a position outside the heart to theprosthesis500 via the elongate flexibleouter member28. Theprosthesis500 may also be provided with means to fix clips orscrews530 to tissue of avalve4 in order to fixateprosthesis500 to that tissue.

Theprosthesis500 may be adapted to be a sub-annular prosthesis (i.e. a prosthesis, that is adapted to be placed and/or fixated close to heart valve4 (e.g. the annulus4cthereof) on a side of theventricular chamber4bof heart valve4) and may serve to change a perimeter of the natural annulus4c, e.g. to reduce the perimeter or modify the shape of the annulus4cin order to treat valve insufficiency. In this respect, theprosthesis500 may be adapted to carry out annuloplasty (i.e. annuloplastic surgery). Further below an exemplary method of using atreatment catheter system2 including aprosthesis500 to carry out annuloplasty will be described.

All embodiments of thetreatment catheter system2 may comprise positioning and/or orientation devices to facilitate relative and/or absolute positioning of thecatheter member8 and the elongate flexibleouter member28. These devices may include passive markers (e.g. marker members) that are fixedly attached tocatheter member8 and/or the elongate flexibleouter member28. The passive markers may be made from materials different from the materials of thecatheter member8 and/or the elongate flexibleouter member28 in order to improve contrast during medical imaging, e.g. using magnetic resonance or X-ray based imaging techniques. The passive markers may e.g. be made of highly radio-opaque materials thereby allowing to precisely acquire the relative and/or absolute position of the components of thetreatment catheter system2 with respect to the body. The passive markers may have an asymmetrical shape to allow identifying the absolute and/or relative position and orientation and thereby the position and orientation of thecatheter member8 and/or the elongate flexibleouter member28. Thelateral groove22 of thecatheter member8 and/or the elongate flexibleouter member28 may have passive markers fixedly attached to facilitate positioning them relative to each other using imaging techniques, e.g. passive markers made of highly radio-opaque materials when imaging techniques based on electro-magnetic radiation (e.g. X-ray imaging) are used. In addition and/or as an alternative, thelateral groove22 and/or other parts/components of thecatheter member8 and/or the elongate flexibleouter member28 may be made from radio-opaque materials. Other positioning and/or orientation devices can include “active devices”, i.e. devices that emit and receive a signal, e.g. an ultra-sonic signal or a X-ray signal or generally an electro-magnetic signal and are configured to determine relative and/or absolute positions of the components (e.g. thecatheter member8 and the elongate flexible outer member28) of thesurgical tools system2 and/or organs of the human/animal body (e.g. the heart) and/or parts of organs of the living body (e.g. a mitral valve4). These active devices may be a part of thecatheter member8 and/or theouter member catheter29 or the elongate flexibleouter member28 or some components (e.g. signal generator, transmitter and/or receiver) of the active devices may be a part of thecatheter member8 and/or theouter member catheter29, while other components (e.g. a signal processing device and/or a display device) of the active devices may be placed outside the human body. Thecatheter member8 may also comprise a metal detector capable of detecting metals (e.g. by using an alternating electric current passing through a wire coil and measuring the resulting magnetic field, which is a function of size, distance and/or material of surrounding matter). The elongate flexibleouter member28 may comprise passive markers or consist of a material with a high magnetic permeability (e.g. iron, nickel, cobalt) to facilitate detection by a metal detector, that is e.g. positioned in thecatheter member8, and to thereby allow measuring a distance and/or relative position between elongate flexibleouter member28 andcatheter member8. Thecatheter member8 an/or theouter member catheter29 may also comprise a glass fiber attached to a lens system provided on the distal end portions thereof to allow optical detection of an absolute or relative position ofcatheter member8 and the elongate flexibleouter member28. The glass fiber and lens system may also be configured to transmit light from an external light source into the heart. The distal end portions ofcatheter member8 and/orouter member catheter29 may also comprise active light sources, e.g. light emitting diodes. In all embodiments, theouter member catheter29 and/or thecatheter member8 may comprise an ultra-sound generator, transmitter and receiver to send and receive ultra-sonic audio signals in order to obtain sonograms of thevalve4,catheter member8 and/or elongate flexibleouter member28. In some embodiments, “active” and “passive” means are used operating together, i.e. the imaging capability of an active means device is improved by using adequate “passive” markers. In some embodiments, only passive “markers” together with external imaging (e.g. a signal generator, signal transmitter and signal receiver positioned outside the living body) are used.

A method of immobilizing a circumferential heart valve tissue structure for example using the treatment catheter system as described above may comprise:

• • arranging an elongate, for example flexible,outer member28 to fully or only partially extend around a perimeter of a circumferential heart valve tissue structure,
  • arranging acatheter member8, on which alateral groove22 opens towards the lateral outside of the catheter member, at the interior of the circumferential heart valve tissue structure, in a manner so that theouter member28 and thelateral groove22 are aligned with each other,
  • reducing a radial distance D1 between theouter member28 and thecatheter member8 to force valve tissue of heartvalve tissue structure6 into thelateral groove22 to catch and to thereby immobilizevalve tissue6 in thelateral groove22 of thecatheter member8.

The method may further comprise one or more of:

• • removing thecatheter member8 and/or theouter member28 form theheart valve4,
  • arranging theouter member28 to fully extend or only partially extend around, e.g. only around one quarter or one third or one half or three quarters around an outer perimeter of circumferential heartvalve tissue structure6.

To placecatheter member8 and/or theouter member28 at the heart valve, the following approaches may be applied: 1) an arterial retrograde approach (e.g. the femoral artery through a puncture in the groin) entering the heart cavity over the aorta, 2) through a venous access possibly associated with a puncture through the inter atrial septum (trans-septal approach), 3) over a puncture through the apex of the heart (trans-apical approach), 4) over a puncture through the atrial wall from outside the heart, or 5) any other approach known to a skilled person.

Further, the method may comprise forwarding a catching component including thelateral groove22, the catchingcomponent20 may be formed by a grid-type or mesh-type cage36, through aninner lumen14 of thecatheter member8 to be exposed to the outside at thedistal end portion16 of thecatheter member8.

In one embodiment, the method may comprise a method for surgical treatment of abloodstream valve4 having a circumferentialvalve tissue structure6. The method may comprise advancing atreatment catheter system2 as described above into a vicinity of thebloodstream valve4 placing thelateral groove22 of thecatheter member8 in an interior10 of the circumferentialvalve tissue structure6; placing the elongateouter member28 at least partially around an outside of thecircumferential tissue structure6 at an axial level, with respect to thelongitudinal axis12, of thelateral groove22; reducing a distance D1 between the elongateouter member28 and thelateral groove22 so as to at least partially force tissue of the circumferentialvalve tissue structure6 into thelateral groove22; and removing thecatheter member8 and the elongateouter member28 from the patient.

The outer member28 (which may be sheathed in an outer member catheter29) and thecatheter member8 may be inserted via the same insertion approach or inserted using a different approach forouter member28 andcatheter member8 respectively.

Reducing the radial distance D1 betweenouter member28 andcatheter member8 may comprise reducing a distance D1 by reducing a length of theouter member28 and/or by increasing a diameter of thecage36, e.g. by using a catchingmechanism32.

Further interaction and/or treatment may comprise fixating one ormore anchors50 or anchors50 withchords52 to tissue, delivering substances or drugs and/or medical imaging. Further, a temporaryartificial heart valve42 may be forwarded to theheart valve4 during interaction and/or treatment as described above in order to prevent valve insufficiency, the temporaryartificial heart valve42 may be fixedly attached to the catchingcomponent20. Fixating anchors50 and delivery of substances or drugs may comprise using aperforation tool48 as described above. Medical imaging may comprise using active and/or passive means as described above. Fixating one ormore anchors50 may include to join two, three, four, five or a plurality of tissue layer together.

Removal of thecatheter member8 and/or theouter component28 may comprise retracting thecage36 and/or the temporaryartificial heart valve42 into thedistal end portion16 of thecatheter member8, thereby increasing a radial distance D1 betweenouter member28 andcatheter member8. Removal may also comprise increasing a radial distance D1 betweenouter member28 andcatheter member8 by increasing the length of theouter member28, e.g. by using the catchingmechanism32 or by straining the outer member28 (i.e. using elastic properties of the outer member).

Thecatheter member8 and/or theouter member28 may be retracted from the heart using the same approaches through which they were inserted.

With reference toFIG. 7 toFIG. 9, exemplary methods for using thetreatment catheter system2 are described. One exemplary method described is called the “Alfieri technique” and is used to create two separate openings for the blood to flow through thenative leaflets4 of the mitral valve.

FIG. 7 shows a view of a human heart with a view from the leftatrial chamber4bonto themitral valve4. The elongate flexibleouter member28 located on the ventricular side of the mitral valve4 (i.e. inFIG. 6 below the mitral valve4) is indicated by a dotted line. The elongate flexibleouter member28 is arranged to only partially surround the circumferential mitralvalve tissue structure6 in theventricular chamber4a(seeFIG. 1) and to extend diametrically transverse to the longitudinal direction of the circumferential heartvalve tissue structure6. However, in other embodiments, the elongate flexibleouter member28 may be arranged to fully extend around a perimeter of aheart valve4. InFIG. 7, thecatheter member8 can be seen extending from theventricular chamber4avia themitral valve4 to theatrial chamber4b.Arrow66 indicates the position and orientation of the catchingopening26 of thelateral groove22 of thecatheter member8. The elongate flexibleouter member28 is inserted via percutaneous approach and the catchingmechanism32 that is configured to decrease or increase a radial distance D1 between the elongate flexibleouter member28 can be schematically seen outside the heart.

FIG. 8 shows a further stage of the method for using thetreatment catheter system2.FIG. 8 shows a view of the human heart with a view from the leftatrial chamber4bonto themitral valve4. The elongate flexibleouter member28 located on the ventricular side of the mitral valve4 (i.e. inFIG. 6 below mitral valve4) is indicated by a dotted line. Thecatheter member8 can be seen extending from theventricular chamber4avia themitral valve4 to theatrial chamber4bArrow66 indicates the position and orientation of the catchingopening26 of thelateral groove22 of thecatheter member8. A radial distance D1 between the elongate flexibleouter member28 and thecatheter member8 has been reduced by the catchingmechanism32, resulting in that heart valve circumferential tissue from two diametrically opposite sides of the circumferential heartvalve tissue structure6 of themitral valve4 is caught and immobilized in thelateral groove22 via the catchingopening26. Theperforation component48 is equipped with an anchor50 (schematically shown) in order to fix tissue of two diametral sides of thevalve4 together. Theperforation component48 equipped with theanchor50 as described above is extended to perforate the tissue caught and immobilized in thelateral catching groove22. When theperforation component48 is retracted afterwards, theanchor50 stays in place and fixes thetissue6 of two diametral sides ofvalve4 together.

FIG. 9 shows a further stage of the method for using thetreatment catheter system2.FIG. 9 shows a view of the human heart with a view from the leftatrial chamber4bonto themitral valve4. The elongate flexibleouter member28 located on the ventricular side of the mitral valve4 (e.g. inFIG. 6 below mitral valve4) is indicated by a dotted line. InFIG. 9, a radial distance D1 between the elongated flexibleouter member28 and thecatheter member8 has been increased, releasing thevalve tissue6 caught and immobilized in thelateral groove22. Then, thecatheter member8 is moved away from the vicinity of thevalve4 and is no longer visible inFIG. 9. Eventually, thecatheter member8 is removed completely from the body. However,anchor50 remains fixated to thevalve tissue6 joining together tissue from two diametral sides of thevalve4. The elongate flexibleouter member28 is shown in the process of being retracted from the heart. Once the elongate flexibleouter member28 is fully retracted from the heart, a method for using atreatment catheter system2 according to one embodiment is completed, leaving only ananchor50 that is joining togethertissue6 of to diametral sides of themitral valve4 behind in the heart.

Using thetreatment catheter system2 as described above to immobilize tissue may enable attachment of a prosthesis to the immobilized tissue. Such a prosthesis may not be part of thetreatment catheter system2 or it may be a part of thetreatment catheter system2. According to an aspect of the invention as described below, the elongate flexibleouter member28 may not only serve to force tissue into thelateral groove22, but may also serve to guide a prosthesis to an intended location close to abloodstream valve4. According to aspects of the invention the catheter member8 (e.g. the catchingcomponent20, e.g. the catchingcomponent20 when formed as a wire cage36) may be provided with a temporaryartificial heart valve42 so that a valve function of thevalve4 that is to be treated (and is e.g. immobilized) is provided while thetreatment catheter system2 is used. This may enable prolonged operation times without damage to a patient due to interrupted blood circulation, which in turn allows a surgeon to more efficiently carry out treatment due to reduced time constraints.

With further reference toFIGS. 13a, 13band14, a method to carry out surgical treatment of tissue of aheart valve4 is described. The method may comprise catching and immobilizing tissue of the heart valve4 (e.g. the circumferential valve tissue structure6) via the catchingopening26 in thelateral groove22 substantially as described above. More specifically, the method may comprise placingcatheter member8 having a catching component20 (e.g. formed as a cage body36) with alateral groove22 as described above close to theheart valve4, e.g. close tomitral valve4 on the side of theventricular chamber4a, on the interior10 of circumferentialvalve tissue structure6 using an approach as described above, e.g. an approach via the apex of the heart. During the approach to the position close to theheart valve4, the catching component20 (including lateral groove22) may be retracted into theinner lumen14 ofcatheter member8. If this is the case and when the position close to theheart valve4 is reached, the method may optionally (e.g. when the catchingcomponent20 is moveable relative to the catheter member8) comprise forwarding the catchingcomponent20 from theinner lumen14 ofcatheter member8 in a distal direction oflongitudinal axis12 in order to expose the catching component20 (e.g. formed as a cage body36) having thegroove22.

The method may further comprise placing thelateral groove22 close to the annulus4cof theheart valve4. According to aspects of the invention, thegroove22 may be placed on theventricular side4aof the annulus4c(sub-annular placement). In this respect, thegroove22 may be placed by moving thecatheter member8 relative to the annulus4cand/or by moving the catching component20 (that may e.g. be formed as a wire cage36) relative to thecatheter member8.

Before, while or after thelateral groove22 is placed as described above, the method may also comprise using the outer member catheter28 (and/or other means) to place the elongate flexibleouter member28 at least partially or fully around tissue of the circumferential valve tissue structure6 (that is on the outside ofcircumferential tissue structure6, i.e. e.g. betweencircumferential tissue structure6 and a wall of theventricular chamber4a). The method may comprise placing the elongate flexibleouter member28 on the outside of the circumferential tissue structure at an axial level (axial e.g. with respect to thelongitudinal axis12 of the catheter member8) of thelateral groove22.

The method may further comprise changing, e.g. reducing, the distance D1 between the catching component20 (and/or thelateral groove22 thereof) and the elongate flexibleouter member28. This may result in tissue, that is located between thelateral groove22 and the elongate flexible outer member28 (e.g. tissue of the circumferentialvalve tissue structure6, e.g. a sub-annular portion thereof), being forced into thelateral groove22 and being immobilized therein. In other words, the method may comprise immobilizing tissue using thecatheter member8 and the elongate flexibleouter member28 by reducing a distance betweencatheter member8 and the elongate flexibleouter member28.

The method may further comprise placing a prosthesis,e.g. prosthesis500 as described above, close to the annulus4cof theheart valve4, e.g. close to the annulus4con a side of theventricular chamber4a. Placement of the (or a) prosthesis may take place when the tissue is fully immobilized, substantially immobilized or when the tissue is not immobilized (i.e. after, while and/or before the distance D1 is reduced or at any other time). Specifically, placing theprosthesis500 may comprise placing theprosthesis500 on the elongate flexibleouter member28 so that theinner lumen520 of prosthesis is received by the elongate flexible outer member28 (this is schematically indicated inFIG. 14, wherein the elongate flexibleouter member28 is indicated by a dashedline28 that is collinear with thelongitudinal axis510 of theprosthesis500, however theprosthesis500 may also be provided separate from the elongate flexible outer member28). For example, theprosthesis500 may be placed around the elongate flexibleouter member28 on a proximal end of the elongate flexible outer member28 (e.g. at or close to the position of the catching mechanism32) and may be moved in a distal direction of the elongate flexibleouter member28 towards theheart valve4. Theprosthesis500 may then be placed on the elongate flexibleouter member28 at an intended position close to the annulus4c. In other word, the method may comprise placing theprosthesis500 on an intended position close to the annulus4c(e.g. sub-annularly on a side of theventricular chamber4a) using the elongate flexibleouter member28 as a guiding means for precise placement, e.g. for precise placement on a circumference of the annulus4c. Placing theprosthesis500 may result in a situation in which tissue is immobilized by the elongate flexibleouter member28 inside thelateral groove22 while the prosthesis is placed on the elongate flexibleouter member28 and is at least partially or fully located inside thelateral groove22. According to aspects of the method, the distance D1 is only reduced when theprosthesis500 is substantially placed on the elongate flexibleouter member28 as intended, as a movement of theprosthesis500 may be easier when the distance D1 betweencatheter member8 andouter member29 is not fully reduced. However, due to a flexibility/elasticity of the catching component20 (e.g. when it is formed as cage body36),outer member29,prosthesis500 and/or biological tissue, theprosthesis500 may also be placed on the intended position when the distance D1 is reduced and tissue is substantially fully caught and immobilized in thelateral groove22. The distance D1 may also be reduced, so that tissue is partially caught in thelateral groove22, then theprosthesis500 may be placed on its intended position using the elongate flexibleouter member28 as a guide, and when theprosthesis500 is placed as intended, the distance D1 may be further reduced to fully immobilize the tissue in thelateral groove22. In this respect it is to be noted that a reduction of distance D1, may equal a reduction of the perimeter that the elongate flexibleouter member28 defines around thecircumferential tissue structure6 and/or increasing a diameter of catching component20 (e.g. via radial expansion as described above with reference toFIG. 4). Accordingly, a dimension ofprosthesis500 that is located on the elongate flexibleouter member28 aroundcircumferential tissue structure6 may be changed together with a change of the perimeter that is defined by the elongate flexibleouter member28. Accordingly, by handling the elongate flexibleouter member28 and/or catheter member8 (e.g. catching component20, e.g. wire cage36) to change the distance D1 between the elongate flexibleouter member28 and catheter member8 (e.g. lateral groove22),prosthesis500 may be elastically and/or plastically deformed to assume an intended shape as defined e.g. by angle α, radius R1, length L and/or diameters D3 and D4 that may be favorable for annuloplasty or other treatment. Further, the method may comprise using other catheters or means (not shown) that may not be a part oftreatment catheter system2 to change a shape, size, rigidity or other characteristics ofprosthesis500 and/or to fixateprosthesis500. That is, theprosthesis500 may also be separate from the elongate flexibleouter member28 and may be guided to its intended position using means other than elongate flexibleouter member28.

The method may also comprise fixating the prosthesis to tissue of thevalve4, e.g. fixating theprosthesis500 to tissue of thecircumferential tissue structure6 as asub-annular prosthesis500. Fixating theprosthesis500 may comprise using thecatheter member8 and/or catchingmember20 comprising thelateral groove22 to push or move theprosthesis500 that is located at least partially on the elongate flexibleouter member28 and inside thelateral groove22 in a direction of the annulus4c, e.g. in a direction from theventricular chamber4atowards the annulus4c. In order to push or move theprosthesis500 towards the annulus to be in close contact to tissue of the annulus4c, the method may comprise pushing or moving thecatheter member8 in a distal direction ofcatheter member8 so that theprosthesis500, that is located at least partially in thelateral groove22, is brought into close contact with tissue of the annulus4cor tissue close thereto via a force that is exerted on theprosthesis500 via thecatheter member8, catchingcomponent20 and/or the lateral groove22 (and optionally as well via tissue, that might be located inside thelateral groove22 along with the elongate flexibleouter member28 and/or the prosthesis500).

Fixatingprosthesis500 may be carried out when theprosthesis500 is pushed against tissue as described above in order to improve contact between the tissue and theprosthesis500. Fixating theprosthesis500 may optionally also comprise permanently fixating theprosthesis500. Permanently fixating may herein refer to fixating theprosthesis500 so that it may remain in the heart after surgical treatment is finished andcatheter member8 and/or the elongate flexibleouter member28 are removed from the heart. However, it does not necessarily imply that the connection betweenprosthesis500 and tissue (e.g. annulus4c) may not be reversible, e.g. during further surgical treatment. Theprosthesis500 may be permanently fixated using sutures, staples, hooks, clips or screws530 as schematically shown inFIGS. 13aandb.

According to the present invention, the method step(s) of fixating (e.g. permanently fixating) theprosthesis500 may be carried out before, while or after the distance D1 is reduced, which may also mean before, while or afterprosthesis500, that is at least partially located on the elongate flexibleouter member28, is elastically and/or plastically deformed as described above. Instead of fixating aprosthesis500, any other treatment may be carried out when tissue of thevalve4 is immobilized by thetreatment catheter system2.

The method of carrying out surgical treatment may further comprise retracting thecatheter member8 and/or the elongate flexible outer member28 (c.f.FIG. 13b). InFIG. 13b, the radial distance D1 between the elongate flexibleouter member28 and thecatheter member8 has been increased, releasing the (valve)tissue6 caught and immobilized in thelateral groove22. Then, thecatheter member8 is moved away from the vicinity of thevalve4. Moving thecatheter member8 away from thevalve4 may comprise moving thecatheter member8 and/or retracting the catching component20 (e.g. cage body36) at least partially or fully into theinner lumen14 ofcatheter member8. Eventually, thecatheter member8 may be removed completely from the body. Further, the elongate flexibleouter member28 may be removed from thevalve4. Removing the elongate flexibleouter member28 may comprise moving (e.g. pulling or pushing) elongate flexibleouter member28 through theinner lumen520 of prosthesis500 (that may be fixated to tissue). However,prosthesis500 may remain fixated to the annulus4c(e.g. using hooks, screws orclips530 or the like).

Using the above described method or a part thereof of may allow prolonged surgical treatment of immobilized heart tissue as temporaryartificial valve42 may control blood flow during surgery whilelateral groove22 and the tissue caught therein may serve as a seal to block bloodflow bypassing the temporaryartificial valve42.

Any method described herein may also optionally comprise anesthetizing a patient for a substantially defined, continuous interval of time. Anesthetizing the patient for a continuous time interval may be the first step of any method of using thetreatment catheter system2. Further, in any method that is described herein, placement of the lateral groove22 (i.e. of the catheter member8) and the elongate flexibleouter member28 close to abloodstream valve4, as well as treatment of tissue using the treatment catheter system2 (e.g. fixing aprosthesis500 to the valve4) and removal ofcatheter member8 and/or the elongate flexible outer member28 (and e.g. outer member catheter29) from the patient may be carried out during said continuous time interval.

Further, any method herein may comprise aligning thelongitudinal axis12 of catheter member8 (e.g. catching component20, e.g. cage body36) and theaxial direction4dthat is defined between two heart chambers so that they are substantially parallel to each other and or are collinear.

While a method for surgical treatment using a prosthesis and a method for placing ananchor50 have been described independently, according to thepresent invention anchor50 andprosthesis500 may be placed and/or fixated at the same time. Accordingly, a method of using atreatment catheter2 according to the present invention may comprise any combination or sub-combination of the method steps described herein as well as of method steps that are not explicitly disclosed as method steps but rather as physical features oftreatment catheter system2. Accordingly, any use or interaction of a physical feature oftreatment catheter system2 may also be a method step for a method of using thetreatment catheter system2 and vice versa.

Claims (26)

What is claimed is:

1. A treatment catheter system for treatment of a bloodstream valve having a circumferential valve tissue structure, comprising

an elongate catheter member to be disposed at the interior of the circumferential valve tissue structure and to be removed therefrom after treatment, the elongate catheter member extending along a longitudinal axis and having an inner lumen and proximal and distal end portions, the elongate catheter member comprising

a catching component that is formed by a cage and is or can be positioned at the distal end portion of the elongate catheter member and is non-separable from the elongate catheter member at least when being positioned at the distal end portion of the elongate catheter member, and that at least when being positioned at the distal end portion of the elongate catheter member comprises a lateral groove provided as a circumferential groove formed in an outer circumferential surface of the cage, the lateral groove extending transverse to the longitudinal axis and opening to a lateral outer side so as to form a lateral catching opening,

an elongate flexible outer member to be disposed at the exterior of the valve structure at a level of the lateral groove, the elongate flexible outer member being capable of at least partially extending circumferentially around the catheter member with valve tissue of the circumferential valve tissue structure being correspondingly circumferentially arranged between the elongate catheter member and the elongate flexible outer member, and

a catching mechanism operable to reduce a radial distance between the elongate catheter member and the elongate flexible outer member so as to catch at least part of the valve tissue between the outer member and the elongate catheter member within the lateral groove via the catching opening to thereby immobilize the caught valve tissue on the distal end portion of the elongate catheter member.

2. The treatment catheter system according toclaim 1, wherein the catching component is moveable relative to the elongate catheter member and can be forwarded and retracted or otherwise exposed via the inner lumen of the elongate catheter member.

3. The treatment catheter system according toclaim 1, wherein the catching component is integrally formed with the elongate catheter member at the distal end portion of the elongate catheter member.

4. The treatment catheter system according toclaim 1, wherein the cage is provided to be radially compressible and expandable so that it can be accommodated within the inner lumen of the elongate catheter member in a radially compressed condition and can be expanded or self-expands at the distal end portion of the elongate catheter member.

5. The treatment catheter system according toclaim 4, wherein the wires are connected to each other by a substantially non-compressible front body having a rounded outer side and having an outer diameter slightly larger than an inner cross-sectional diameter of the lumen of the elongate catheter member to be able to provide a plug for closing a frontal end opening of the inner lumen of the elongate catheter member.

6. The treatment catheter system according toclaim 1, wherein the cage is formed by a plurality of elongate wires substantially extending along the longitudinal axis of the elongate catheter member and being angularly spaced around the longitudinal axis of the elongate catheter member, the elongate wires each comprise a radially and inwardly bended bending portion, the bending portions forming the lateral groove.

7. The treatment catheter system according toclaim 6, wherein each wire is provided in and moveable relative to a sheath which is provided in the lumen of the elongate catheter member and moveable relative to the elongate catheter member.

8. The treatment catheter system according toclaim 1, wherein the catching component comprises a blunt front part.

9. The treatment catheter system according toclaim 1, further comprising an elongate flexible perforation component which can be forwarded through the inner lumen of the elongate catheter member to the distal end portion of the elongate catheter member and which is operable such as to provide a perforation through the valve tissue caught in the lateral groove or through valve tissue adjacent to the caught valve tissue.

10. The treatment catheter system according toclaim 9, wherein the perforation component is formed by a needle which is provided and arranged such as to be forwarded into the lateral groove.

11. The treatment catheter system according toclaim 9, further comprising an anchor component which can be forwarded through the inner lumen of the elongate catheter member and can be placed within the caught valve tissue or within adjacent valve tissue, wherein

the perforation component is hollow, and

the anchor component is provided such that it can be forwarded through the perforation component to the distal end portion of the elongate catheter member.

12. The treatment catheter system according toclaim 1, further comprising an anchor component which can be forwarded through the inner lumen of the elongate catheter member and can be placed within the caught valve tissue or within adjacent valve tissue.

13. The treatment catheter system according toclaim 12, further comprising a chord attached to the anchor component.

14. The treatment catheter system according toclaim 1, further comprising a medical drug supplying component which is provided such that it can be forwarded through the inner lumen of the elongate catheter member to the distal end portion of the elongate catheter member and such that it can forward a medical drug to the caught valve tissue or the adjacent valve tissue.

15. The treatment catheter system according toclaim 14, further comprising an elongate flexible perforation component which can be forwarded through the inner lumen of the elongate catheter member to the distal end portion of the elongate catheter member and which is operable such as to provide a perforation through the valve tissue caught in the lateral groove or through valve tissue adjacent to the caught valve tissue, wherein

the perforation component is hollow, and

the medical drug supplying component is provided such that it can be forwarded to the distal end portion of the elongate catheter member through the perforation component.

16. The treatment catheter system according toclaim 1, further comprising marker members fixedly attached on the catheter member and the elongate flexible outer member, wherein the marker members are made from a material different than the material of the elongate catheter member and outer member respectively, to allow identifying relative positions and orientations of the elongate catheter member and the elongate flexible outer member using material-sensitive imaging techniques.

17. The treatment catheter system according toclaim 1, wherein

the catching component and the elongate flexible outer member each comprise an electrode which is electrically connected to an electric energy source, and

the electrodes of the catching component and the elongate flexible outer member selectively produce an electric field between each other using electric energy supplied from the energy source to open holes in cell membranes of the valve tissue.

18. The treatment catheter system according toclaim 1, wherein the catching component is provided with an artificial heart valve.

19. The treatment catheter system according toclaim 1, wherein

the elongate flexible outer member is provided with a prosthesis having an inner lumen that at least partially receives the elongate flexible outer member to be slideable along a longitudinal direction of the elongate flexible outer member, and

the prosthesis is configured to be fixated to the bloodstream valve.

20. The treatment catheter system according toclaim 19, wherein

the prosthesis has an outer cross-sectional diameter that is defined in a radial direction of a longitudinal axis of the prosthesis, that is smaller than a width of the lateral groove in a direction of the longitudinal axis of the elongate catheter member.

21. A method for surgical treatment of a bloodstream valve having a circumferential valve tissue structure, the method comprising:

advancing the treatment catheter system according toclaim 1 into a vicinity of the bloodstream valve;

placing the lateral groove of the catheter member in an interior of the circumferential valve tissue structure;

placing the elongate outer member at least partially around an outside of the circumferential tissue structure at an axial level, with respect to the longitudinal axis, of the lateral groove;

reducing a distance between the elongate outer member and the lateral groove so as to at least partially force tissue of the circumferential valve tissue structure into the lateral groove; and

removing the catheter member and the elongate outer member from the patient.

22. A treatment catheter system for treatment of a bloodstream valve having a circumferential valve tissue structure, comprising

an elongate catheter member to be disposed at the interior of the circumferential valve tissue structure and to be removed therefrom after treatment, the elongate catheter member extending along a longitudinal axis and having an inner lumen and proximal and distal end portions, the elongate catheter member comprising

a catching component that is provided with an artificial heart valve and is or can be positioned at the distal end portion of the elongate catheter member and is non-separable from the elongate catheter member at least when being positioned at the distal end portion of the elongate catheter member, and that at least when being positioned at the distal end portion of the elongate catheter member comprises a lateral groove that extends transverse to the longitudinal axis and that opens to a lateral outer side so as to form a lateral catching opening,

an elongate flexible outer member to be disposed at the exterior of the valve structure at a level of the lateral groove, the elongate flexible outer member being capable of at least partially extending circumferentially around the catheter member with valve tissue of the circumferential valve tissue structure being correspondingly circumferentially arranged between the elongate catheter member and the elongate flexible outer member, and

a catching mechanism operable to reduce a radial distance between the elongate catheter member and the elongate flexible outer member so as to catch at least part of the valve tissue between the outer member and the elongate catheter member within the lateral groove via the catching opening to thereby immobilize the caught valve tissue on the distal end portion of the elongate catheter member.

23. The treatment catheter system according toclaim 22, wherein the catching component is formed by a tubular sleeve having a lateral cutout extending in a transverse direction of the longitudinal axis of the elongate catheter member and forming the lateral groove.

24. A method for surgical treatment of a bloodstream valve comprising a circumferential valve tissue structure of a patient using the treatment catheter system according toclaim 22, the method comprising

placing the lateral groove of the catheter member in an interior of the circumferential valve tissue structure,

placing the elongate outer member at least partially around an outside of the circumferential tissue structure at an axial level, with respect to the longitudinal axis, of the lateral groove,

reducing a distance between the elongate outer member and the lateral groove so as to at least partially force tissue of the circumferential valve tissue structure into the lateral groove, and

removing the catheter member and the elongate outer member from the patient.

25. The method according toclaim 24, wherein

the blood stream valve is a mitral valve connecting a ventricular chamber with an atrial chamber and having a valve annulus and the circumferential valve tissue structure on a side of the ventricular chamber, and wherein

placing the lateral groove comprises placing the lateral groove in the ventricular chamber close to the annulus.

26. The method according toclaim 25, wherein

the ventricular-chamber and the atrial chamber define an axial direction therebetween, wherein

the treatment catheter system further comprises a prosthesis having an inner lumen at least partially receiving the elongate outer member, and wherein

reducing the distance comprises forcing at least a part of the prosthesis into the lateral groove, and wherein

the method further comprises moving the lateral groove in an axial direction of the valve towards the annulus so that the prosthesis is in close contact with the annulus, and

fixing the prosthesis to the annulus.

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